scholarly journals Antimicrobial preservation efficacy of liquid glucose and liquid maltitol syrups with and without 0.1% sorbic acid

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Thomas Carpentier ◽  
Eve Maillard ◽  
Mathilde Royer ◽  
Lina Mustapha ◽  
Frédéric Marçon
Keyword(s):  
Shelf Life ◽  
Sorbic Acid ◽  
The Self ◽  
Active Pharmaceutical Ingredients ◽  
Liquid Formulation ◽  
European Pharmacopoeia ◽  
Acceptance Criteria ◽  
Pharmaceutical Ingredients ◽  
Aspergillus Brasiliensis ◽  
Glucose Syrup

Abstract Objectives Amongst paediatric pharmaceutical forms, syrups offer advantages such as ease of administration and good palatability. They also exhibited microbial self-preservation properties that may be useful to enhance shelf life of liquid formulation. The objective of our works is to test the self-preservation efficacy of maltitol and glucose syrup without or with sorbic acid as described in the European pharmacopoeia. Methods The European Pharmacopoeia test of antimicrobial preservation efficacy was performed on liquid glucose syrup and liquid maltitol syrup with and without 0.1% sorbic acid. Results Unpreserved glucose and maltitol syrups did not meet the European Pharmacopoeia acceptance criteria for antimicrobial preservative efficacy due to the regrowth of Aspergillus brasiliensis on day 28 whereas glucose and maltitol syrups with 0.1% sorbic acid pass the test. Conclusions The addition of a preservative (sorbic acid) in glucose and maltitol syrups allows the validation of the antimicrobial preservative efficacy test of the European Pharmacopoeia. Further tests are needed to see if preservative efficacy is maintained despite dilutions or in the presence of active pharmaceutical ingredients.

scholarly journals Self-assembled sorbitol-derived supramolecular hydrogels for the controlled encapsulation and release of active pharmaceutical ingredients

2015 ◽  
Vol 51 (35) ◽  
pp. 7451-7454 ◽  
Author(s):  
Edward J. Howe ◽  
Babatunde O. Okesola ◽  
David K. Smith
Keyword(s):  
Drug Release ◽  
Controlled Drug Release ◽  
The Self ◽  
Active Pharmaceutical Ingredients ◽  
Supramolecular Hydrogel ◽  
Pharmaceutical Ingredients ◽  
Inflammatory Drugs ◽  
Anti Inflammatory ◽  
Self Assembled ◽  
Ph Controlled

A simple supramolecular hydrogel is able to extract acid-functionalised anti-inflammatory drugs via directed interactions with the self-assembled gel nanofibres and exhibits pH-controlled drug release.

scholarly journals Effectiveness of Antimicrobial Preservation of Extemporaneous Diluted Simple Syrup Vehicles for Pediatrics

2018 ◽  
Vol 23 (5) ◽  
pp. 405-409 ◽  
Author(s):  
Ana Santoveña-Estévez ◽  
Javier Suárez-González ◽  
Martín Vera ◽  
Cristina González-Martín ◽  
Mabel Soriano ◽  
...  
Keyword(s):  
Propylene Glycol ◽  
Microbiological Quality ◽  
Quality Criteria ◽  
Toxic Effects ◽  
Active Pharmaceutical Ingredients ◽  
European Pharmacopoeia ◽  
Vulnerable Group ◽  
Minimum Quantity ◽  
Pharmaceutical Ingredients ◽  
Microbiological Criteria

OBJECTIVES Extemporaneous or magistral formulation of active pharmaceutical ingredients using traditional compounding techniques is a common practice when no commercial form is available for pediatrics. For this vulnerable group of patients, the formulation must be prepared with the minimum quantity and lowest proportion of excipients approved for pediatrics, avoiding the use of preservatives. Often the vehicles used for these preparations are dilutions of simple syrup with water. The objective of this study is to assess the effectiveness of antimicrobial preservation in simple syrup diluted with aqua conservans (conserved water), without propylene glycol or with a reduced proportion of parabens. METHODS The European Pharmacopoeia test of efficacy of antimicrobial preservation was applied to 5 trial vehicles prepared with simple syrup diluted with water. RESULTS Simple syrup is stable during 14 days. Vehicles prepared with simple syrup diluted with purified water did not meet the microbiological quality criteria, but when they are diluted with water that incorporates propylene glycol and parabens (aqua conservans), then they meet the criteria. In addition, if the water is prepared with parabens and without propylene glycol, the criteria for the dilution are met. Nevertheless, if the dilution is done with water prepared with an insufficient proportion of parabens to act as preservatives, the dilution does not meet the pharmacopoeia microbiological criteria. CONCLUSIONS Dilution of simple syrup (50:50 v/v) to prepare a vehicle for extemporaneous or magistral preparation is microbiologically safe when water with methylparaben and propylparaben is used in a proportion of 0.08% and 0.02% (w/w), respectively, avoiding the use of propylene glycol as a solvent and thus its toxic effects in pediatrics.

scholarly journals Selective preparation of elusive and alternative single component polymorphic solid forms through multi-component crystallisation routes

2016 ◽  
Vol 52 (46) ◽  
pp. 7372-7375 ◽  
Author(s):  
Lynne H. Thomas ◽  
Craig Wales ◽  
Chick C. Wilson
Keyword(s):  
Self Assembly ◽  
Single Component ◽  
The Self ◽  
Active Pharmaceutical Ingredients ◽  
Simple Route ◽  
Pharmaceutical Ingredients ◽  
Crystallisation Process ◽  
Polymorphic Forms

A transferable, simple, route to previously elusive and novel polymorphic forms of important active pharmaceutical ingredients is demonstrated using N-heterocyclic co-molecules to influence the self-assembly crystallisation process in a multi-component environment.

scholarly journals Substantiation of technology for obtaining capsules of a multi-component drug with neurotropic action

2021 ◽  
pp. 10-16
Author(s):  
Maksym Almakaiev ◽  
Larysa Sidenko
Keyword(s):  
Fluidized Bed ◽  
Disodium Salt ◽  
Wet Granulation ◽  
Thioctic Acid ◽  
Active Pharmaceutical Ingredients ◽  
Pyridoxine Hydrochloride ◽  
Acceptance Criteria ◽  
Average Mass ◽  
Pharmaceutical Ingredients ◽  
Mixing Method

The aim of the work. Theoretical and experimental substantiation of a rational technology for obtaining a preparation in the form of capsules based on uridine-5-monophosphate of disodium salt, cytidine-5-monophosphate of disodium salt, vitamin B6, thioctic acid and magnesium lactate dihydrate, determination of process parameters that can affect critical quality characteristics active pharmaceutical ingredients in the product and establishing acceptance criteria for each critical process parameter to be used in batch production and process control. Materials and methods. Objects of the research: masses for encapsulation, granulates and the finished product - capsules with the conventional name “Neuronucleos”. To obtain capsules, active pharmaceutical ingredients (API) were used: uridine-5-monophosphate disodium salt and cytidine-5-monophosphate disodium salt (Shanghai Oripharm Co. Ltd., China), thioctic acid (Shanghai Modern Pharmaceutical Co., Ltd..”, China), pyridoxine hydrochloride (“DSM Nutritional Products GmbH”, Germany), magnesium lactate (“Moes Cantabra S.L.”, Spain). The quality indicators were studied: description, average mass of content and uniformity of mass, uniformity of dosage units, dissolution, accompanying impurities, quantitative content of API. Methods of liquid chromatography and complexometric titration were used. Results. It has been established that the use of the direct mixing method does not allow obtaining a mass for encapsulation corresponding to the indicator "Bulk density". The use of the wet granulation method in a fluidized bed has been substantiated. It has been shown that it is difficult to perform granulation in a fluidized bed of an API mixture containing thioctic acid. It has been established that it is rational to obtain a mass for encapsulation in two stages: obtaining a granulate from magnesium lactate dihydrate and pyridoxine hydrochloride with a moisturizer solution (sorbitol + uridine-5-monophosphate disodium salt + cytidine-5-monophosphate disodium salt) and then obtaining a mass for encapsulation from granulate, thioctic acid, anhydrous colloidal silicon dioxide and magnesium stearate by the direct mixing method. Conclusions. On the basis of the performed technological research and analysis of the quality of the obtained capsules, a method for obtaining a capsule mass using the method of wet granulation in a fluidized bed was chosen. The granulation mode was substantiated and the optimal parameters for obtaining a high-quality product were selected, the acceptance criteria for each critical parameter of the technological process were established

scholarly journals Developing and evaluation of orodispersible tablets containing caffeine

2021 ◽  
Vol 14 (1) ◽  
pp. 34-40
Author(s):  
Robert-Alexandru Vlad ◽  
◽  
Elena-Beatrice Trifan ◽  
Paula Antonoaea ◽  
Emőke-Margit Rédai ◽  
...  
Keyword(s):  
Point Of View ◽  
Direct Compression ◽  
Active Pharmaceutical Ingredients ◽  
European Pharmacopoeia ◽  
Disintegration Time ◽  
Pharmaceutical Ingredients ◽  
Sodium Starch Glycolate ◽  
Orodispersible Tablets ◽  
Formulation Variables

Starting from the premise that a reduced number of active pharmaceutical ingredients (APIs) are used to treat hypotension, the aim of this study consisted of developing new formulations of caffeine-orodispersible tablets (CAFODTs). The formulation variables were the type of disintegrant and its concentration. The CAF-ODTs were prepared by direct compression, (CAF1, CAF2 and, CAF3) each of them containing 100 mg of CAF / tablet. The proposed formulations were analyzed from a pharmacotechnical point of view. For the formulations developed the tablets’ physical appearance, resistance to crushing, friability, disintegration behaviour, and the in vitro caffeine release were evaluated. White tablets, with a resistance to crushing decreasing in the following order CAF1 > CAF2 > CAF3 were obtained. The friability test showed that all the formulations are respecting the in-force European Pharmacopoeia (Ph. Eur. 10) requirements with values less than 1 %. The disintegration time for all three formulations was less than 180 seconds, the smallest time being registered in the case of CAF2 formulation, where Sodium Starch Glycolate (SSG) was used as a disintegrant (24-30 s, as a result of the different methods used. Through the in vitro releasing study, it was observed that over 99.9 % caffeine was released from all three analyzed formulations. By investigating the amount of caffeine released after 1 minute, it can be noticed that the largest amount released was recorded in CAF2 formulations, where SSG was used as a disintegrant. Compared to CAF2, the amount of CAF released was reduced to half, after the first five minutes for CAF1 formulation, where sodium croscarmellose was used, and ten times lower in the case of CAF3 where no disintegrant was used. Based on the results obtained we can conclude that all three formulations are respecting the pharmacotechnical in-force officinal requirements. The presence of SSG in the CAF2 formulation led to obtaining tablets with a reduced disintegration time in comparison to the other two formulations proposed in this study.

Reversed-Phase High Performance Liquid Chromatographic Analysis of Three First Line Anti-Tuberculosis Drugs

2019 ◽  
Vol 69 (12) ◽  
pp. 3590-3592
Author(s):  
Nela Bibire ◽  
Romeo Iulian Olariu ◽  
Luminita Agoroaei ◽  
Madalina Vieriu ◽  
Alina Diana Panainte ◽  
...  
Keyword(s):  
High Performance ◽  
Biological Fluids ◽  
Gradient Elution ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Assay Method ◽  
Active Pharmaceutical Ingredients ◽  
First Line ◽  
Pharmaceutical Ingredients ◽  
Liquid Chromatographic

Active pharmaceutical ingredients such as isoniazid, pyrazinamide and rifampicin are among the most important first-line anti-tuberculosis drugs. A simple, rapid and sensitive reversed phase-high performance liquid chromatographic assay method for the simultaneous determination of isoniazid, pyrazinamide and rifampicin has been developed. Separation of the interest compounds was achieved in a 10 min chromatographic run in gradient elution mode on a Zorbax SB-C18 stainless steel column (150 � 4 mm, 5 mm) using a guard column containing the same stationary phase. The gradient elution was carried out with a mobile phase of 10% CH3CN aqueous solution for channel A and 50% CH3CN in pH = 6.8 phosphate buffer (20 mM), to which 1.5 mL triethylamine were added for channel B. Quantification of the analyzed substances was carried out spectrophotometrically at 269 nm. Detection limits of 0.48 mg/L for isoniazid, 0.52 mg/L for pyrazinamide and 0.48 mg/L for rifampicin were established for the developed assay method. The present work showed that the proposed analysis method was advantageous for simple and rapid analysis of the active pharmaceutical ingredients in pharmaceuticals and biological fluids.

scholarly journals Numaswitch: an efficient high-titer expression platform to produce peptides and small proteins

AMB Express ◽  
2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Bach-Ngan Nguyen ◽  
Florian Tieves ◽  
Thomas Rohr ◽  
Hilke Wobst ◽  
Felix S. Schöpf ◽  
...  
Keyword(s):  
Fermentation Broth ◽  
High Titer ◽  
New Technology ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Expression Platform ◽  
Small Proteins ◽  
Production Platform ◽  
Β Amyloid ◽  
Cost Efficient

AbstractThe production of peptides as active pharmaceutical ingredients (APIs) by recombinant technologies is of emerging interest. A reliable production platform, however, is still missing due the inherent characteristics of peptides such as proteolytic sensitivity, aggregation and cytotoxicity. We have developed a new technology named Numaswitch solving present limitations. Numaswitch was successfully employed for the production of diverse peptides and small proteins varying in length, physicochemical and functional characteristics, including Teriparatide, Linaclotide, human β-amyloid and Serum amyloid A3. Additionally, the potential of Numaswitch for a cost-efficient commercial production is demonstrated yielding > 2 g Teriparatide per liter fermentation broth in a quality meeting API standard.

scholarly journals Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging

Molecules ◽  
2021 ◽  
Vol 26 (3) ◽  
pp. 610
Author(s):  
Mariann Inga Van Meter ◽  
Salah M. Khan ◽  
Brynne V. Taulbee-Cotton ◽  
Nathan H. Dimmitt ◽  
Nathan D. Hubbard ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Mass Spectrometry Imaging ◽  
Laser Desorption ◽  
Ionization Mass Spectrometry ◽  
Ionization Mass ◽  
Active Pharmaceutical Ingredients ◽  
Laser Desorption Ionization ◽  
Over The Counter ◽  
Pharmaceutical Ingredients ◽  
Desorption Ionization

Agglomeration of active pharmaceutical ingredients (API) in tablets can lead to decreased bioavailability in some enabling formulations. In a previous study, we determined that crystalline APIs can be detected as agglomeration in tablets formulated with amorphous acetaminophen tablets. Multiple method advancements are presented to better resolve agglomeration caused by crystallinity in standard tablets. In this study, we also evaluate three “budget” over-the-counter headache medications (subsequently labeled as brands A, B, and C) for agglomeration of the three APIs in the formulation: Acetaminophen, aspirin, and caffeine. Electrospray laser desorption ionization mass spectrometry imaging (ELDI-MSI) was used to diagnose agglomeration in the tablets by creating molecular images and observing the spatial distributions of the APIs. Brand A had virtually no agglomeration or clustering of the active ingredients. Brand B had extensive clustering of aspirin and caffeine, but acetaminophen was observed in near equal abundance across the tablet. Brand C also had extensive clustering of aspirin and caffeine, and minor clustering of acetaminophen. These results show that agglomeration with active ingredients in over-the-counter tablets can be simultaneously detected using ELDI-MS imaging.

scholarly journals Sulfanyl Porphyrazines with Morpholinylethyl Periphery—Synthesis, Electrochemistry, and Photocatalytic Studies after Deposition on Titanium(IV) Oxide P25 Nanoparticles

Molecules ◽  
2021 ◽  
Vol 26 (8) ◽  
pp. 2280
Author(s):  
Tomasz Koczorowski ◽  
Wojciech Szczolko ◽  
Anna Teubert ◽  
Tomasz Goslinski
Keyword(s):  
Diclofenac Sodium ◽  
2D Nmr ◽  
Oxide Nanoparticles ◽  
Electrochemical Studies ◽  
Macrocyclic Compounds ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Vis Spectroscopy ◽  
Singlet Oxygen Quencher ◽  
Nmr Techniques

The syntheses, spectral UV–Vis, NMR, and electrochemical as well as photocatalytic properties of novel magnesium(II) and zinc(II) symmetrical sulfanyl porphyrazines with 2-(morpholin-4-yl)ethylsulfanyl peripheral substituents are presented. Both porphyrazine derivatives were synthesized in cyclotetramerization reactions and subsequently embedded on the surface of commercially available P25 titanium(IV) oxide nanoparticles. The obtained macrocyclic compounds were broadly characterized by ESI MS spectrometry, 1D and 2D NMR techniques, UV–Vis spectroscopy, and subjected to electrochemical studies. Both hybrid materials, consisting of porphyrazine derivatives embedded on the titanium(IV) oxide nanoparticles’ surface, were characterized in terms of particle size and distribution. Next, they were subjected to photocatalytic studies with 1,3-diphenylisobenzofuran, a known singlet oxygen quencher. The applicability of the obtained hybrid material consisting of titanium(IV) oxide P25 nanoparticles and magnesium(II) porphyrazine derivative was assessed in photocatalytic studies with selected active pharmaceutical ingredients, such as diclofenac sodium salt and ibuprofen.

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